* FDA asked for more information on drug in June
* Eliquis also awaiting European approval decision
* Seen as important drug in market for new blood clot
Sept 26 U.S. health regulators set a date of
March 17 to decide whether to approve a closely watched blood
clot preventer developed by Bristol-Myers Squibb Co and
Pfizer Inc for use in patients with atrial fibrillation,
the companies said on Wednesday.
The U.S. Food and Drug Administration in June declined to
approve the drug, Eliquis, and asked the companies to provide
more information on a pivotal clinical trial of the medicine,
which is designed to reduce the risk of stroke caused by blood
clots in heart patients.
Wall Street and the medical community widely expect approval
of Eliquis, known chemically as apixaban, and see it becoming a
major player in an estimated $10 billion market for new
alternatives to the decades old blood thinner warfarin.
Atrial fibrillation, a common form of dangerously irregular
heartbeat, is seen as by far the largest and most important use
for the new blood clot preventers. Some 12 million people in the
United States and Europe have the condition, which puts them at
high risk of suffering a stroke.
Eliquis is also awaiting an approval decision in Europe,
where a committee of experts for European regulators last week
recommended its approval.
The drug proved to be more effective in clinical trials than
warfarin, which must be closely monitored to prevent dangerous
If approved, Eliquis will compete with Xarelto from Bayer
and Johnson & Johnson and Boehringer